Who may legally offer which services?

Legal Requirements for Performing Genetic Analysis

In Germany, Austria and Switzerland, performing genetic analysis is legally regulated for the protection of the patient. The German Genetic Diagnosis Law, Austrian Genetic Technology Law and the Swiss Genetic Diagnosis Law are very similar in this respect, while most other countries do not legally regulate genetic analyses. All three regulations classify genetic analysis as either non-medicinal (“lifestyle”) or medicinal. The German Genetic Diagnosis Law distinguishes between the following three categories of genetic tests:

GERMANY

Genetic Examination (Lifestyle Genetics Test) (§ GenDG) (§3 GenDG)

Product group

TOXO SENSOR

Definition (§3 GenDG):(§3 GenDG)

An examination of genetic traits that makes no medical diagnosis.

May be performed by:

Anyone. Testing privileges are not restricted to doctors or any other professionals. This type of analysis can be carried out in the gym, on the Internet and by both doctors and practitioners of alternative medicine. (§7 GenDG)(§7 GenDG)

can predict a disease which will develop in the future (not the risk of this occurring)

identifies the gene carrying a mutation which could lead to diseases in offspring

May be performed by:

Specially trained doctors only. This includes specialists in human genetics as well as other doctors who have received qualifications for genetic examination as part of their medical training. (§7 GenDG) (§7 GenDG)

This means that all medical genetic analyses in Germany may only be performed by doctors, while non-medical genetic analyses can be done by fitness trainers, nutritionists, practitioners of alternative medicine and other members of the general populace.